Home / Recalls / Suntech Medical, Inc. / Z-0810-2020

Z-0810-2020 Class II Terminated

Recalled by Suntech Medical, Inc. — Morrisville, NC

Recall Details

Product Type: Devices
Report Date: January 22, 2020
Initiation Date: December 11, 2019
Termination Date: April 10, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 384 units

Product Description

Model 250D Ambulatory Blood Pressure Monitor labeled under the following brands: Bravo Mini, part number 99-0233-00; Agilis Mini, part number NJ124 (99-0233-40); and NBP One, part number NBP One (99-0233-10).

Reason for Recall

The Bravo Mini (Model 250D), Agilis Mini (Model 250D), and NBP One (Model 250D) are being recalled because of a user safety issue when rechargeable batteries are misused in the product.

Distribution Pattern

No US Distribution; Internationally distributed to France, S. America

Code Information

All serial numbers.